Cleared Traditional

K800822 - CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE

K800822 is an FDA 510(k) clearance for CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE, manufactured by Kli. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K800822 · Kli · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
64d
Days
Class 2
Risk

K800822 is an FDA 510(k) clearance for the CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Kli (Mchenry, US). The FDA issued a Cleared decision on June 17, 1980 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kli devices

FDA 510(k) Submission Details - K800822

510(k) Number K800822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1980
Decision Date June 17, 1980
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 131d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 39
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K800822.
1512M/F WIRE ELECTRODE NEEDLE SET
K823432 · Life-Tech Intl., Inc. · Nov 1982
UROCOMP MODEL 1404
K821939 · Life-Tech Intl., Inc. · Jul 1982
LIFE-TECH #'S 1106/1156 UROLABS
K812178 · Life-Tech Instruments, Inc. · Aug 1981
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
K790519 · American Medical Systems, Inc. · May 1979
UROFLOW-CYSTOMETER SYSTEM
K771850 · Richard Wolf Medical Instruments Corp. · Oct 1977
CATHETER, URETHRAL PRESSURE, UPE-10 & 12
K770579 · Life-Tech Instruments, Inc. · May 1977